CardioFocus HeartLight™ Endoscopic Ablation System Enables Treatment of Atrial Fibrillation: Live Case and Abstract Presented at EHRA EUROPACE 2011
-- New Data Reinforces Ability of Device to Achieve High Acute Pulmonary Vein Isolation --
MARLBOROUGH, Mass., June 29, 2011 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight™ Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announced today that its technology was featured in a live case and scientific abstract presented at the European Heart Rhythm Association (EHRA) EUROPACE 2011 congress on June 28 in Madrid, Spain.
The case, "Atrial fibrillation ablation using laser balloon technology," demonstrated successful isolation of all pulmonary veins in a single procedure with HeartLight EAS. Presenters Vivek Y. Reddy, MD, of Mount Sinai School of Medicine, New York, USA and Petr Neuzil, MD, of Na Homolce Hospital, Prague, Czech Republic, performed the ablation on a 69-year-old male with paroxysmal AF at Na Homolce Hospital.
"The advantages offered by HeartLight EAS made it a very favorable system to address the patient's atrial fibrillation," said Dr. Reddy. "The system offers direct visualization of the heart tissue, which helped ensure contiguity of the ablation lesions. Clinical data indicates that because of this, HeartLight EAS offers an improved ability to achieve durable, reproducible PV isolation."
Additionally, an abstract presentation, "Is pure visually guided pulmonary vein isolation feasible using an endoscopic ablation system?," examined the use of HeartLight EAS in 35 patients with drug-refractory atrial fibrillation. In a single procedure, HeartLight EAS with the aid of a supplemental spiral catheter achieved an acute pulmonary vein (PV) isolation rate of 98%. Among the 18 patients completing six months follow up, 78% were in stable sinus rhythm without antiarrhythmic drugs.
"The compliant balloon catheter enables optimal visualization and tissue contact," said Julian Chun, MD, of Cardioangiologisches Centrum Bethanien, Frankfurt, Germany and one of the presenting physicians. "Physicians can use the technology to isolate all veins, regardless of individual anatomy, and with minimal repositioning for a more efficient procedure that may translate to improved PV isolation."
Stephen Sagon, President and CEO of CardioFocus Inc., commented, "The scientific sessions at EUROPACE further validate the potential benefits of HeartLight EAS in treating atrial fibrillation patients. In particular, the live case demonstrated how the system enables physicians to truly see within the heart and visually direct the application of laser energy to achieve PV isolation within a single procedure."
About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). Its novel HeartLight™ Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.
The HeartLight Endoscopic Ablation System received CE Mark in 2009 for the treatment of atrial fibrillation, and is commercially available at leading institutions throughout Europe. The device is investigational in the U.S., with a pivotal study expected to commence in 2011. CardioFocus is headquartered in Marlborough, MA. For more information on the company and its technology, please visit www.CardioFocus.com.
The scientific information discussed in this news release is preliminary and investigative. The CardioFocus HeartLight Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.
SOURCE CardioFocus, Inc.
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